Kornimate/medical-research-clean huggingface dataset:
to investigate the efficacy of treatment with oral na-921 (bionetide) versus placebo in females with rett syndrome

Conditions: Rett Syndrome

Summary: primary objective • to investigate the efficacy of treatment with oral bionetide versus placebo in girls and women with rett syndrome key secondary objective • to investigate the efficacy of treatment with oral bionetide versus placebo on ability to communicate in girls and women with rett syndrome

co-primary endpoints * rett syndrome behavior questionnaire (rsbq) total score - change from baseline to week 12 * clinical global impression-improvement (cgi-i) score at week 12 key secondary endpoint change from baseline to week 12 in: • communication and symbolic behavior scales developmental profile™ infant-toddler checklist- social composite score (csbs-dp-it social)

Eligibility criteria:
inclusion criteria 1. female subjects 5 to 20 years of age, inclusive, at screening 2. body weight ≥12 kg at screening 3. can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube 4. has classic/typical rett syndrome (rtt) 5. has a documented disease-causing mutation in the mecp2 gene 6. has a stable pattern of seizures, or has had no seizures, within 8 weeks of screening 7. subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. subject must not be pregnant or breastfeeding. 8. the subject's caregiver is english-speaking and has sufficient language skills to complete the caregiver assessments 9. subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to screening exclusion criteria 1. has been treated with insulin within 12 weeks of baseline 2. has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study 3. has a history of, or current, cerebrovascular disease or brain trauma 4. has significant, uncorrected visual or uncorrected hearing impairment 5. has a history of, or current, malignancy 6. has a known history or symptoms of long qt syndrome

Keywords: rett syndrome, genetic diseases, x-linked
the serum lipid profiles in itp: a retrospective study

Conditions: Immune Thrombocytopenia

Summary: the project was retrospectively undertaking by qilu hospital of shandong university in china. in order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in itp.

background: immune thrombocytopenia (itp) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. platelet indices changes depending on the morphology and volume of platelets. serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices. objectives: to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in itp. methods: the clinical data from 457 itp patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for immune thrombocytopenia. exclusion criteria: * (1) receiving platelet transfusion within 7 days or itp-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.

Keywords: immune thrombocytopenia
maternal oxygen administration for fetal distress ii

Conditions: Oxygen Inhalation Therapy; Labour; Fetal Distress

Summary: supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. however, oxygen delivery depends not just on arterial oxygen content but also on perfusion. maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. however, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades. the investigators found the use of 2 l/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery ph value or the fetal heart rate (fhr) pattern distribution.


Eligibility criteria:
inclusion criteria: at term (\>37 weeks, \<42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category i fhr tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent. exclusion criteria: respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received o2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.
effects of different omeprazole dosing on gastric ph in non-variceal upper gastrointestinal bleeding

Conditions: Non-variceal Upper Gastrointestinal Bleeding

Summary: the aim of the study is to identify the best method of omeprazole (ome) application with respect to intragastric ph, cytochrome p450 2c19 (cyp2c19) genotype and phenotype.

the patients with non-variceal upper gastrointestinal bleeding (nvugib) are prospectively enrolled. after the achievement of endoscopic hemostasis, the patients are randomized to 40-mg intravenous (i.v.) ome bolus injection every 12 h or 8-mg/h continuous i.v. infusion for 72 h after an 80-mg i.v. ome bolus administration. the intragastric ph is recorded for 72 h. the cyp2c19 variant alleles (\*2, \*3, \*17) are analyzed and the serum concentrations of ome and 5-hydroxyomeprazole (5-oh ome) are determined. the diagnosis of helicobacter pylori infection was based on the results of the rapid urease test performed on stomach mucosa biopsies (antrum and angle) and on the results of the stool antigen test.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any treatment or assessment is performed * patients admitted with upper gastrointestinal bleeding (ugib) symptoms to the emergency department of the university hospital of bialystok (bialystok, poland) exclusion criteria: * pregnancy * age \>90 years * lack of written consent * recent treatment with certain medications, including ppis, h2-receptor antagonists (h2ra), antacids, steroids, oral contraceptives, clopidogrel, prasugrel and clarithromycin * the presence of variceal ugib * history of surgery of upper gastro-intestinal tract

Keywords: cyp2c19 helicobacter pylori non-variceal upper gastrointestinal bleeding intragastric ph proton pump inhibitor
comparison of the clinical efficacy and safety of endoscopic superior rectal mucosal ligation and hemorrhoids ligation

Conditions: Hemorrhoids

Summary: endoscopic superior rectal mucosal ligation and hemorrhoids ligation are two types of endoscopic ligation, the aim of this study is to compare the clinical efficacy and safety of these two approaches.if you accept this study,you need to provide case information before the operation, complete the endoscopic treatment according to the routine colonoscopy procedure, and follow-up survey after the operation.


Eligibility criteria:
inclusion criteria: 1. according to the goligher classification in the chinese guidelines for the diagnosis and treatment of hemorrhoids (2020) , patients who are diagnosed with grade ii-iii internal hemorrhoids . 2. patients who voluntarily participate and sign the informed consent form. exclusion criteria: 1. patients who had severe heart, liver, and kidney disease. 2. patients who had severe immune deficiency. 3. patient\&#39;s general condition is too poor to tolerate endoscopic therapy. 4. patients had a history of pelvic chemoradiotherapy. 5. patients had severe infection or inflammatory lesion in the rectum or anal canal,or the rectum or anal canal had undergone surgery. 6. patient is a pregnant woman. 7. patients who disagree with endoscopic treatment and are concerned about the possible risks refused to sign the informed consent form. 8. the follow-up time is insufficient and the clinical data were incomplete.
cart19 cells treatment of mrd of b cell malignancies and then auto-hsct

Conditions: Leukemia, Lymphocytic, Acute, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell

Summary: the clinical study of cart19 cells treatment for mrd of b cell malignancies and then auto-hsct

the clinical study of the chimeric antigen receptor t cells (cart cells) treatment for minimal residual disease(mrd) of b cell malignancies and then autologous hematopoietic stem cell transplantation(auto-hsct).

Eligibility criteria:
inclusion criteria: 1. patients with cd19+, b cell acute lymphocytic leukemia(b-all), b cell chronic lymphocytic leukemia(b-cll), b cell lymphoma，who have 0.01%≤mrd\<10% during upfront treatment 2. patients must be within 12 months of initial b-all, b-cll, b cell lymphoma diagnosis 3. patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (pcr) analysis 4. age 14 years to 75 years 5. adequate organ function defined as: 1. ast and alt ≤ 3 times upper limit of normal range for age, 2. serum creatinine ≤ 1.6 mg/dl, 3. direct bilirubin ≤2.0 mg/dl, 4. adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia, 5. cardiac left ventricle ejection fraction (lvef) ≥ 40% confirmed by echo/muga. 6. patients with cns disease will be eligible if cns disease is responsive to therapy 7. expression of cd19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. adequate performance status defined as ecog performance status 0 or 1 9. provides written informed consent 10. subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol exclusion criteria: 1. active, uncontrolled infection 2. active hepatitis b or hepatitis c 3. hiv infection 4. class iii/iv cardiovascular disability according to the new york heart association classification 5. subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment 6. pregnant or nursing (lactating) women patients with a known history or prior diagnosis of optic neuritis or other 7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
helicobacter pylori and acute alcohol induced pancreatitis

Conditions: Pancreatitis, Acute; Helicobacter Infections

Summary: this study is performed to measure wether helicobacter pylori has an effect on the incidence and course of acute alcohol induced pancreatitis

a recent pilot study unexpectedly discovered, that helicobacter pylori infection was rare in patients having their first acute alcohol induced pancreatitis (aaip) when compared to subjects with similar alcohol use but no history of pancreatitis. this subject has not been studied in humans until now. therefore we seek to study, with a larger material, wether aaip is associated with lower prevalence of helicobacter pylori, by measuring the antibodies against helicobacter pylori from the sera of aaip patients and from a control group of alcoholics with no history of aaip.

Eligibility criteria:
inclusion criteria: * acute alcohol pancreatitis (first) exclusion criteria: * death during hospitalization

Keywords: retrospective length of stay helicobacter pylori
bioequivalence of nomegestrol acetate (nomac) and estradiol (e2) in commercial versus phase 3 pivotal clinical batches of nomac-e2 tablets (p06328)

Conditions: Healthy Postmenopausal Females

Summary: for the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (nomac) with estradiol (e2). this was an open-label, randomized, single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at two sites, one site per study part. the primary objective of part 1 was to assess the bioequivalence of nomac and e2 of the drug product manufactured using the commercial process ("commercial batch") versus the phase 3 drug product ("batch a"). the primary objective of part 2 was to assess bioequivalence of nomac and e2 of the drug product manufactured using the commercial process ("commercial batch") versus the phase 3 drug product ("batch b").


Eligibility criteria:
key inclusion criteria: * healthy postmenopausal females between the ages of 45 and 70 years, inclusive, having a body mass index (bmi) between 18 and 32, inclusive; * free of any clinically significant disease that would interfere with the study evaluations. key exclusion criteria: * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug; * history of any infectious disease that affected the subject's ability to participate in the trial; * history of alcohol or drug abuse in the past 2 years; * previously received nomac-e2; * current participation in another clinical study or had participated in a clinical study (eg, laboratory or clinical evaluation) within 30 days of baseline; * smoked more than 10 cigarettes or equivalent tobacco use per day; * history of malignancy; * contraindications for the use of contraceptive steroids; * recent history of medication use of certain medications specified in the protocol.
dentin hypersensitivity - varnish or laser?

Conditions: Dentin Hypersensitivity

Summary: dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. the variety of treatment options and products on the market might seem overwhelming. this study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. patients will be divided randomly into four groups (control group (gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). visual analog scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. mixed anova's and descriptive analysis will be used for statistical evaluation.

a total of 80 patients meeting the inclusion criteria will be included in this randomized clinical study. participants will be randomly divided into four groups. pain scores will be measured before treatment, right after treatment, 1 month after treatment and 3 months after treatment using the visual analog scala (vas). patients will not know which treatment will be performed before nor will the patients from the laser groups know the wavelengths. pain scores at check-up meetings will be collected by another doctor other than the one who will perform all laser treatments.

Eligibility criteria:
inclusion criteria: * all genders * 18-70 years * good general health * at least two hypersensitive teeth in either jaw * initial vas-score \>3 exclusion criteria: * active carious lesions, insufficient restorations, enamel cracks, reversible pulpitis * active periodontal disease, periodontal surgery (in the last 6 months) * bleaching procedure in the last 3 months * analgetic use in the last 72 hours * pregnant/lactating women
acute comfort and blur of systane and optive

Conditions: Dry Eye

Summary: to evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.


Eligibility criteria:
inclusion criteria: * healthy, normal eyes or documented diagnosis of dry eye exclusion criteria: * must not have worn contact lenses for 7 days preceding enrollment

Keywords: dry eye
comparison of kinesiotaping and pressure garment on women with upper extremity lymphedema following mastectomy

Conditions: Breast Cancer Lymphedema

Summary: breast cancer is a standout amongst the most widely recognized cancer among women. it is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems this study aimed to compare the effects of kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer. material and methods: in this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to kinesio taping (kt) group (n=33) and pressure garment (pg) group (n=33). the kt group received kinesio taping application, while the pg group received pressure garment (40-60 mmhg) for at least 15-18 hours per day through the study. all patients were evaluated to record the changes of the limb circumference, shoulder pain and disability index (spadi), hand grip strength and quality of life at baseline and end of intervention.

66 women with unilateral breast cancer related to lymphedema (stage ii and iii) for at least for 6 months were invited to participate in the study. lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. the participants were randomly assigned to 2 groups. kinesio taping group included 33 patients receiving kinesio taping (kt) and pressure garment (pg) included 33 patients. the exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis. all patients were evaluated to record the changes of the limb circumference, shoulder pain and disability index (spadi), hand grip strength and quality of life

Eligibility criteria:
inclusion criteria: * unilateral breast cancer related to lymphedema (stage ii and iii) for at least for 6 months were invited to participate in the study. lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. exclusion criteria: * the exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
effects of tofacitinib on body composition, bone mineral density and bone marrow adiposity in patients with rheumatoid arthritis: the tofat project

Conditions: Rheumatoid Arthritis

Summary: inflammatory rheumatic diseases (ird), such as rheumatoid arthritis, are characterized by adverse changes in body composition. lean mass and bone mineral density are usually reduced while adiposity (total fat mass, visceral adiposity...) is increased in comparison with healthy controls. many factors may influence the body composition of those patients such as aging, disease modifying anti-rheumatic drugs (dmards), nutrition and physical activity. however, data on body composition and adverse changes under dmards in patients with rheumatoid arthritis (ra) are actually scarce. this is the case with tofacitinib (targeted synthetic dmard or tsdmard) while preliminary data let us think that this treatment may influence body composition and bone mineral density. this study is going to be the first to focus on changes in body composition (fat mass and lean mass), bone mineral density and bone marrow adiposity under tofacitinib.


Eligibility criteria:
inclusion criteria: * adult patient's ≥18 years old with moderately to severely active rheumatoid arthritis (ra) (acr/eular criteria ) * previously untreated with janus kinase (jak) inhibitors * with an indication for tofacitinib will be eligible. * all patients will have to be treated with tofacitinib either alone or with methotrexate. -healthy volunteers should be ≥18 years old. exclusion criteria: * • treatment with more than three anti-tumor necrosis factor alpha (tnfα). patients who were receiving anti-tnfα will be required a washout period lasting at least five-half-lives before to start tofacitinib, * previously exposed to jak inhibitors, * patients who were receiving non-anti-tnfα biologics (abatacept, tocilizumab, sarilumab or rituximab) will be required a washout period lasting at least five-half-lives before to start tofacitinib * concomitant methotrexate (mtx) will be permitted if started ≥3 months prior to study start and at a stable dose (≤25 mg/week) for ≥4 weeks. * history or discovery of an osteoporotic fracture and/or t-score≤-3 if ≥50 years and/or z-score ≤-3 if \<50 years during the screening phase, * current treatment with oral corticosteroids higher than 10 mg prednisone/day, * pathologies or treatments that could affect the bone metabolism (breast cancer with aromatase inhibitors, gastrointestinal malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...), * weight\> 160 kg, * patients on restrictive diets or considering such a diet during the study period, * patients with an intense exercise program or planning to benefit from it during the study period,

Keywords: rheumatoid arthritis tofacitinib body composition bone marrow adiposity bone marrow density